Catalog Number

LS03200

Brand Name

Diode laser FOX 980 nm.

Version/Model Number

LS03200

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

-

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K073322,K073322

Product Code

GEX

Product Code Name

Powered Laser Surgical Instrument

Public Device Record Key

17a0a402-d3ea-4b6d-996e-3a4ac87fa1fa

Public Version Date

April 07, 2021

Public Version Number

2

DI Record Publish Date

May 08, 2019

Package DI Number

04260155592478

Quantity per Package

1

Contains DI Package

04260155590078

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-